Presentation on theme: "Conflict of Interest: Dartmouth College. Why do we care about it ? Conflict of Interest in Research : Unbiased research: design, conduct, reporting Maintain."— Presentation transcript:
Why do we care about it ? Conflict of Interest in Research : Unbiased research: design, conduct, reporting Maintain public trust in science Protect human subjects Protect researchers Protect Institution
42 CFR Part 50, Subpart F, 45 CFR Part 94 Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought To ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be biased by any conflicting financial interest of an Investigator Conflict of Interest: Why do we care about it?
A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but for years did not report much of this income to university officials, according to information given Congressional investigators. Senator Charles E. Grassley pushed three experts in child psychiatry at Harvard to expose their income from consulting fees. Some of their research is financed by government grants. Like Dr. Biederman, Dr. Wilens belatedly reported earning at least $1.6 million from 2000 to 2007, and another Harvard colleague, Dr. Thomas Spencer, reported earning at least $1 million after being pressed by Mr. Grassley’s investigators. But even these amended disclosures may understate the researchers’ outside income because some entries contradict payment information from drug makers, Mr. Grassley found.
AreaCMEResearch Clinical Practice Offices with responsibility DHMC Center for Continuing Education in Health Sciences DC Provost Office Council Sponsored Activities CPHS Conflict of Interest Committee DHMC DH Integrity Task Force Policies http://ccehs.dartmou th- hitchcock.org/coursed irectors.html http://www.dartmouth.edu/~o sp/resources/policies/dartmout h/cofinterest.html Focus Assuring valid content Free of commercial bias Federal regulations Non human subjects Human Subjects Prescribing practices Establishment of clinical guidelines Speakers bureaus payments COI Complexity: It’s Not Just Research
Dartmouth College - Conflict of Interest COI Research Process Flow DHHS / NIHHuman Subject Reporting threshold via NIH regs = $10K per year Current process: PI Annual Report to Office of Sponsored Projects (OSP) Conflict of Interest Committee (COIC): Faculty, senior administrators Council on Sponsored Activities COIC Recommendation to CPHS CPHS makes final decision Management Plan OSP to notify sponsor if applicable Reporting threshold via guidance = $1 per year Current process: per proposal to Office of the Committee for the Protection of Human Subject (CPHS)
What is the Institutional Response to Conflict of Interest Concerns? 1.Understand the complex spectrum of interrelated activities: Research, Education, Clinician Practice, Business Operations …… 2.Enhance processes around research coi disclosures: Currently paper based process – moving to electronic based. Transition from annual process to project based disclosure process 2/16/10MNW8
COI Process: What is required from the institution? To each Institution that applies for PHS grants or cooperative agreements for research and, through the implementation of this subpart by each Institution, to each Investigator participating in such research Investigator = principal investigator and any other person who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding… includes the Investigator's spouse and dependent children
Ensure the design, conduct, and reporting of research is not biased by any conflicting interest of an Investigator. Promote objectivity in research and to maintain the public trust. By accepting federal funds we need to abide by federal regulations and we have a process in place to do so including the requirement that the college report any identified financial conflict to the sponsoring agency prior to the expenditure of grant funds. Gather information and review of conflicts of interest for research. If a significant financial interest is determined to exist we have a responsibility to manage, reduce, or eliminate the conflict. COI: What is required from the Institution?
COI Process: What is required from each Investigator? c)(1) Require that by the time an application is submitted to PHS each Investigator who is planning to participate in the PHS-funded research has submitted to the designated official(s) a listing of his/ her known Significant Financial Interests (and those of his/her spouse and dependent children): – (i) That would reasonably appear to be affected by the research for which PHS funding is sought; and – (ii) In entities whose financial interests would reasonably appear to be affected by the research. (2) All financial disclosures must be updated during the period of the award, either on an annual basis or as new reportable Significant Financial Interests are obtained.
Quick and simple On-line process Event based, project-specific (e.g. per proposal ) Each Dartmouth key personnel responds concerning their own financial interests PI doesn’t have to respond on behalf of co- Investigators, etc. Two questions. If both questions are responded to as ‘no’ the process is complete. If either question elicits a ‘yes’ response, the individual will be required to complete additional information on-line. Dartmouth College COI Process: What will change?
New COI Process: What 99% will see 1. MANAGEMENT POSITION: Are you (or your spouse or your dependent children) a director, officer, partner, employee or agent of, or hold any position of management with the sponsor of this research proposal? ___ No ___ Yes 2. FINANCIAL INTEREST: Do you (or your spouse or dependent children) have a Significant Financial Interest that would reasonably appear to affect or be affected by the proposed research? ___ No ___ Yes
The revision of our OSP reporting process is primarily driven for two reasons: 1. On-line will be more efficient for researchers, and 2. This process allows us to be in compliance with NIH concerns related to definition of “investigator” and reporting whenever there is a change in potential financial conflict of interest.** Note: the current annual reporting process will be eliminated. To Summarize: